Description

• The Flowflex Plus COVID-19 and Flu A/B Home Test is for use under Emergency Use Authorization (EUA) only
• The Flowflex Plus COVID-19 and Flu A/B Home Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens
• This test is authorized for non-prescription home use with self-collected anterior nares nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals two (2) years or older
• This test is only authorized for individuals with sign and symptoms of respiratory infection consistent with COVID-19 within the first six (6) days of symptom onset when tested at least twice over three days with at least 48 hours between tests
• Positive results indicate the presence of viral antigens, but the clinical correlation with patient history and other diagnostic information is necessary to determine infection status
• Positive results do not rule out bacterial infection or co-infection with other viruses
• Individuals who test positive with the Flowflex Plus COVID-19 and Flu A/B Home Test should self-isolate and seek follow up care with their physician or healthcare provider as additional testing may be necessary
• All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed
• Negative results do not rule out SARS-CoV-2, influenza A, and influenza B infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions such as isolating from others and wearing masks
• Negative results should be considered in the context of an individual’s recent exposures, history, and the presence of clinical signs and symptoms consistent with SARS-CoV-2, influenza A, and influenza B infection
• Easy to use
• Quick results